Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors

Protocol # :
Breast Cancer Survivor
Disease Sites
Principal Investigator
Partridge, Ann, H

Trial Description

The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I
components on insomnia symptoms among breast cancer survivors using a randomized clinical

Eligibility Requirements

Inclusion Criteria:

- Willingness to maintain a consistent dosing pattern if currently taking sleep
medications or using cannabis for sleep

- Females; Age 18+

- Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG

- Completed curative treatment (surgery, radiation, chemotherapy) > 3 months prior to
enrollment [ongoing adjuvant therapy permitted]

- Has not undergone other behavioral sleep treatment within the prior 12 months

- Score greater than or equal to 8 on the Insomnia Severity Index

- Able to understand and speak English

Exclusion Criteria:

- Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg
syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea

- Bi-polar disorder, schizophrenia, initiation of psychological treatment within three
months, alcohol or drug abuse in the prior year (Alcohol >2 drinks/day or consuming 5+
drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety
will not be exclusion criteria.)

- Shift-work in the prior three months or anticipated during the study time

- Planned regular travel out of time zone (>1 hour) during the study period.

- Currently or planning to become pregnant during the study period